UFP Technologies · 22 hours ago
Quality Engineer
Saint Charles, IL
Full-time
Onsite
Senior Level, Lead/Staff
$90K/yr - $120K/yr
10+ years expUFP Technologies is a leader in developing and manufacturing single use safe patient handling systems. The Quality Engineer position ensures that the quality related engineering needs of the organization are met, focusing on compliance, risk analysis, and process validation while collaborating with various teams.
Health CareManufacturingMedical Device
No H1B
Responsibilities
Leads in supporting compliance for medical device manufacturer in ID / Traceability throughout supply chain, well documented and executed Acceptance Activities, Non-conforming material management, Packaging / Labeling control, Production / Process controls, and Process Validation
Conducts Risk Assessments, project meetings, pilot builds, First Article Inspections, and Post Market Risk Management
Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and / or production equipment
Designs and executes pFEMAs and validations protocols including IQ, OQ, PQ and PPQ
Performs Corrective and Preventive Action management, facilitation, ownership and problem resolution
Drives process improvement and support, including Quality System process review and revision
Provides training assistance, including providing training in quality system activities / requirements
Coordinates and Facilitates internal and external audit coordination and facilitation
Performs all other duties as assigned or needed
Qualification
Required
A bachelor's degree in science, engineering or equivalent
10 or more year's relevant experience
At least 5 years' experience in medical device manufacturing
Strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820) with a strong background in medical device quality assurance and processes
Experience conducting supplier audits and writing supplier contracts
Familiarity with statistical analysis
Company
UFP Technologies
UFP Technologies is a designer and custom manufacturer of medical devices, sterile packaging, and engineered custom products.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown1993-12-23IPO
Leadership Team
Mitchell Rock
President
Recent News
The Motley Fool
2026-01-22
2025-12-12
UFP Technologies, Inc.
2025-12-02
Company data provided by crunchbase